OPUSWAVE Dual Sensor Imaging System

The OPUSWAVE Dual Sensor Imaging System is a cart-based console that performs intravascular imaging of coronary arteries using both Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) modalities simultaneously or sequentially through a single DualView Catheter. It is intended for patients undergoing transluminal interventional procedures and provides real-time grayscale imaging with measurement and analysis tools.

The device uses a Motor Drive Unit (MDU) connected to a DualView Catheter capable of dual imaging modalities at 40 MHz IVUS frequency and 1300 nm OCT wavelength with Class 1 laser output. It features a PC-based interface with keyboard and mouse, custom GUI, and supports image export via USB, DVD, network, and optical media. OCT imaging requires coronary flush (saline or contrast), while pullback can be automatic or manual.

IEC 60601-1 for electrical safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60825-1 for laser safety classification, and FDA guidance for software in medical devices (Enhanced level documentation required).

The device has identical intended use to predicate devices iLab Ultrasound Imaging System (K152316) and Ilumien Optis (K141453)—both intravascular coronary imaging for interventional procedures. Technological characteristics are equivalent: same form factor (cart-based console), same IVUS mode and frequency, similar OCT wavelength, equivalent user interfaces, and comparable safety/performance profiles. Design verification, validation, and animal testing demonstrated the device meets user needs without raising new safety or effectiveness issues. The dual-sensor capability is a combination of proven predicate technologies rather than a novel approach.